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What's the Current Status of Celiac Disease Drug Development?


New understanding about celiac disease could lead to drug breakthroughs. Photo: CC--Tom Hart

Celiac.com 07/25/2016 - Celiac disease is one of the most common immune-mediated diseases. Often, a gluten-free diet does not fully control celiac symptoms and disease activity.

Even though no new therapies have been approved, a growing effort, coupled with a rapidly expanding knowledge of the regulatory pathway could soon lead to new breakthroughs.

A team of researchers recently reviewed the epidemiology, pathophysiology, and current treatment paradigm for celiac disease. The researchers were M Wungjiranirun, CP Kelly, and DA Leffler, both of the Division of Gastroenterology at the Celiac Center of Beth Israel Deaconess Medical Center in Boston, Massachusetts, USA.

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They also reviewed the major types of therapies being proposed for celiac treatment, and expounded broadly upon what is known, and what can be predicted concerning the regulatory pathway for approval of a new celiac disease treatment. In the near future, increasingly numerous and diverse therapy options will enter clinical trials. The desired result will be the first approved agents targeting celiac disease treatment outside of a gluten-free diet.

The team notes that, though things like biopsies and blood tests will always be important in therapeutic clinical trials, there is not currently enough evidence to link them with improved patient outcomes, which is required as a baseline for drug approval. This means that patient-reported outcomes will likely be primary end points in Phase III celiac disease trials for some time to come.

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